MEDICAL DEVICES: Conflicts of Interest Common
Because many physicians involved in developing, testing and promoting new medical devices have financial incentives to obtain positive results, decisions about what devices to buy and even what patients to use them on are often based more on prospects for personal gain than on scientific evidence, according to a special report by the New York Times. Although the report focuses on device development in the field of interventional cardiology, which has seen explosive growth in the past decade, it notes that the same conflicts occur in the development of every other type of medical device. The Times found that trials of medical devices often are conducted by physicians who invented the device or are investors or board members of the manufacturer. Likewise, respected physicians often promote devices at venues such as educational conferences without revealing that they stand to profit handsomely if a device sells well. The conflicts created by those relationships have important consequences, experts say, because trials of devices are not subject to rules as stringent as those that apply to drug trials.
The evidence used to support certain devices often amounts to little more than "soapbox testimonials," critics say, because the FDA approved many devices now on the market based solely on data from a registry -- the experience of a group of patients treated with the device, often by the physicians who invented it. Researchers sometimes chose patients for whom they expected particularly positive outcomes, or found reasons not to count results when the device failed to work. The FDA now requires randomized trials to counter potential researcher bias, but device studies still tend to be small, and very few trials compare the results with those obtained from other types of treatments. Further, the Times notes, devices intended for use in the heart, such as stents, are increasingly being used by cardiologists to treat other areas of the body such as the carotid artery-despite the absence of evidence to back up such applications. In some cases, critics say, patients receive improper procedures because cardiologists don't fully understand the areas of the body they're trying to treat. Some physicians say that conflicts are an unavoidable result when doctors are involved in research, and that their impact is overestimated. Manufacturers argue that restricting the roles of physicians in device development would increase costs and slow the process. Critics, however, say the real issue is that more rigorous trials and careful monitoring of physicians' involvement are necessary to maintain scientific and clinical standards (Eichenwald/Kolata, 11/30).